Tumor necrosis factor α inhibitor therapy and cancer risk in chronic immune-mediated diseases

Authors

  • Kevin Haynes,

    Corresponding author
    1. University of Pennsylvania, Philadelphia
    • University of Pennsylvania, Department of Epidemiology and Biostatistics, 713 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104
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  • Timothy Beukelman,

    1. University of Alabama at Birmingham
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    • Dr. Beukelman has received consulting fees, speaking fees, and/or honoraria from Novartis and Genentech (less than $10,000 each) and research funding from Pfizer.

  • Jeffrey R. Curtis,

    1. University of Alabama at Birmingham
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    • Dr. Curtis has received consulting fees, speaking fees, and/or honoraria from Pfizer, Bristol-Myers Squibb, Crescendo Bioscience, and Abbott (less than $10,000 each) and from Roche/Genentech, UCB, Centocor, Amgen, and the Consortium of Rheumatology Researchers of North America (CORRONA) registry (more than $10,000 each); he has received research grants from Pfizer, Bristol-Myers Squibb, Crescendo Bioscience, Abbott, Roche/Genentech, UCB, Centocor, CORRONA, and Amgen.

  • Craig Newcomb,

    1. University of Pennsylvania, Philadelphia
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  • Lisa J. Herrinton,

    1. Kaiser Permanente Northern California, Oakland
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    • Dr. Herrinton has received research contracts from Proctor & Gamble, Genentech, and Centocor.

  • David J. Graham,

    1. FDA, White Oak, Maryland
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  • Daniel H. Solomon,

    1. Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
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    • Dr. Solomon has received consulting fees from CORRONA (more than $10,000) and research grants from Amgen, Abbott, and Eli Lilly and has served in uncompensated roles on clinical trials related to rheumatoid arthritis for the VA Health System and Pfizer.

  • Marie R. Griffin,

    1. Vanderbilt University and Mid-South Geriatric Research Education and Clinical Center, VA Tennessee Valley Health Care System, Nashville
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  • Lang Chen,

    1. University of Alabama at Birmingham
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  • Liyan Liu,

    1. Kaiser Permanente Northern California, Oakland
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  • Kenneth G. Saag,

    1. University of Alabama at Birmingham
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    • Dr. Saag has received consulting fees, speaking fees, and/or honoraria from Eli Lilly, Merck, Savient, Ardea Biosciences, Regeneron, URL Pharma, and Abbott (less than $10,000 each) and from Amgen (more than $10,000).

  • James D. Lewis,

    1. University of Pennsylvania, Philadelphia
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    • Dr. Lewis has received consulting fees, speaking fees, and/or honoraria from GlaxoSmithKline, Millennium Pharmaceuticals, Allos Therapeutics, Amgen, Pfizer, and Abbott (less than $10,000 each) and research grants from Centocor, Takeda, and Shire.

  • on behalf of the SABER Collaboration


  • Statements in this article should not be construed as endorsement by the Agency for Healthcare Research and Quality (AHRQ), FDA, or US Department of Health and Human Services (DHHS).

Abstract

Objective

To compare the incidence of cancer following tumor necrosis factor α (TNFα) inhibitor therapy to that with commonly used alternative therapies across multiple immune-mediated diseases.

Methods

The Safety Assessment of Biological Therapeutics study used data from 4 sources: national Medicaid and Medicare databases, Tennessee Medicaid, pharmacy benefits plans for Medicare beneficiaries in New Jersey and Pennsylvania, and Kaiser Permanente Northern California. Propensity score–adjusted hazard ratios (HRs) and 95% confidence intervals (95% CIs) were computed to estimate the relative rates of cancer, comparing those treated with TNFα inhibitors to those treated with alternative disease-modifying therapies. The cancer-finding algorithm had a positive predictive value ranging from 31% for any leukemia to 89% for female breast cancer.

Results

We included 29,555 patients with rheumatoid arthritis (RA) (13,102 person-years), 6,357 patients with inflammatory bowel disease (1,508 person-years), 1,298 patients with psoriasis (371 person-years), and 2,498 patients with psoriatic arthritis (618 person-years). The incidence of any solid cancer was not elevated in RA (HR 0.80 [95% CI 0.59–1.08]), inflammatory bowel disease (HR 1.42 [95% CI 0.47–4.26]), psoriasis (HR 0.58 [95% CI 0.10–3.31]), or psoriatic arthritis (HR 0.74 [95% CI 0.20–2.76]) during TNFα inhibitor therapy compared to disease-specific alternative therapy. Among RA patients, the incidence of any of the 10 most common cancers in the US and of nonmelanoma skin cancer was not increased with TNFα inhibitor therapy compared to treatment with comparator drugs.

Conclusion

Short-term cancer risk was not elevated among patients treated with TNFα inhibitor therapy relative to commonly used therapies for immune- mediated chronic inflammatory diseases in this study.

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